Home Applications 204835 Application 204835
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEFIXIME CEFIXIME FOR SUSPENSION;ORAL 100MG/5ML No No 002 CEFIXIME CEFIXIME FOR SUSPENSION;ORAL 200MG/5ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204835-001 CEFIXIME CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 A204835-002 CEFIXIME CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65862-751 Cefixime cefixime Aurobindo Pharma Limited ANDA Current 65862-751 Cefixime cefixime Aurobindo Pharma Limited ANDA Current 65862-751 Cefixime cefixime Aurobindo Pharma Limited ANDA Current 65862-751 Cefixime cefixime Aurobindo Pharma Limited ANDA Current 65862-752 Cefixime cefixime Aurobindo Pharma Limited ANDA Current 65862-752 Cefixime cefixime Aurobindo Pharma Limited ANDA Current 65862-752 Cefixime cefixime Aurobindo Pharma Limited ANDA Current 65862-752 Cefixime cefixime Aurobindo Pharma Limited ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 32599 ORIG 2015-04-24